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The Universal
Flu Vaccine
Multi-Season
Multi-Strain
Vaccine
CORPORATE PRESENTATION
Q4 2017
This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction.
All statements in this communication, other than those relating to historical facts, are "forward-looking statements" within the meaning of the United States Private
Litigation Reform Act of 1995.You can identify forward-looking statements by terms including ‘‘anticipates,’’ ‘‘believes,’’ ‘‘could,’’ ‘‘estimates,’’ ‘‘expects,’’ ‘‘intends,’’
‘‘may,’’ ‘‘plans,’’ ‘‘potential,’’ ‘‘predicts,’’ ‘‘projects,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would,’’ and similar expressions intended to identify forward-looking statements. These forward-
looking statements relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business,
operations and financial performance and condition. However, these forward-looking statements are not guarantees of future performance and are subject to a number
of assumptions, involve known and unknown risks, many of which are beyond our control, uncertainties and other factors that may cause our actual results, performance
or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important
factors that could cause actual results to differ materially from our expectations include, among others: the risk that drug development involves a lengthy and expensive
process with uncertain outcome; BiondVax's ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical
trials; the introduction of competing products; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in
receiving the regulatory approvals to commercialize BiondVax's products; the difficulty in evaluating business prospects; lack of sufficient funding to finance the clinical
trials; termination of license agreement with Yeda which is the owner of certain patents, patent applications and other intellectual property, as a result of dispute that can
arise with Yeda or the failure of BiondVax to comply with financial and other terms of the license; the difficulty of predicting actions of the U.S.A FDA; the regulatory
environment and changes in the health policies and regimes in the countries in which we operate; changes in the global pharmaceutical industry; changes in customers’
budgeting priorities; European Medicines Agency and other regulatory authority approvals; natural disasters; labor disputes; rising interest rates; general market, political
or economic conditions in the countries in which we operate; pension and health insurance liabilities; volatility or crises In the financial market; arbitration, litigation and
regulatory proceedings; and war or acts of terror;
Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not
unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot
guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The
risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus
which was declared effective on May 11, 2015. Readers are urged to carefully review and consider the various disclosures made in the Company’s SEC reports, which are
designed to advise interested parties of the risks and factors that may affect its business, financial condition, results of operations and prospects. These forward-looking
statements speak only as of the date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. whether as a
result of new information, future events or otherwise, except as required by law.
SAFE HARBOR STATEMENT
One • For All : The Universal Flu Vaccine
2
BIONDVAX’S 2017 HIGHLIGHTS
1. http://www.biondvax.com/2017/06/biondvaxs-ceo-provides-first-half-2017-general-corporate-update/
2. http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/
3. http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/
4. http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/
5. http://www.biondvax.com/2017/09/biondvax-announces-closing-of-10-million-public-offering-of-american-depositary-shares-and-exercise-of-over-allotment-option/
3
€20 million non-dilutive funding2 – June 19
The European Investment Bank (EIB) signed an agreement to support commercial scale production and Phase 3
BiondVax successfully meets Phase 2b clinical trial endpoints3 – July 20
M-001 showed statistically significant elevated T-cell immune responses, good safety profile and well-tolerated
Israeli government support mid-size commercial facility4 – March 30
Ministry of Economy granted 20% of a NIS 20m budget towards construction
$10 million secondary offering5 – September 18
Following the placement, BiondVax has 3 large strategic investors, each holding 5% to 20%
“…We now have the resources to launch our Phase 3 program
towards commercialization.” 1
Flu
infects
up to 20%
of the
population
each year
… and kills
The Flu Virus: Frequent and Unpredictable Mutations
A SEASONAL PROBLEM… A PANDEMIC THREAT
SEASONAL FLU
• Per year: 23,000 deaths1 (21,000 elderly) &
200,000 hospitalizations2 in just the US
• 8th leading cause of death3 (US), Worldwide death
toll of 250,000-500,000 annually4
• $87B economic burden5 in the US of which $56B
is in the elderly
PANDEMIC FLU
• When?… Where?... Which?… pandemic strain
• Pandemic strain: a new to Humans
• Past century: 4 major pandemics with over
100M deaths5
• The 1918 Spanish Flu cost to global GDP6 was 4.8%
or over $3T in today’s dollars
Bill Gates interviewed by Ezra Klein on VOX
“I rate the chances of a widespread epidemic in my
lifetime at well over 50%”
https://youtu.be/9AEMKudv5p0
5
1 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5933a1.htm#tab2; 2 http://www.cdc.gov/flu/about/qa/disease.htm;
3 http://www.cdc.gov/nchs/fastats/deaths.htm; 4 http://www.who.int/mediacentre/factsheets/fs211/en/
5 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096;
6 1918 Influenza: the Mother of All Pandemics, Volume 12, Number 1—January 2006, CDC; 7 World Bank 2014:Pandemic Risk
CURRENT VACCINE FALLS SHORT: THE MISMATCH
1 Center for Disease Control: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm
2 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
Seasonal Flu Vaccine Effectiveness (VE)
CDC data
1
, flu seasons 2004-2017
Why current solutions fall short…
• Past strains selection  Mismatch
phenomenon
• Previous season’s vaccine will not necessarily
protect against next season’s flu strains
• 4-6 month production lag
As low as
9% VE
in elderly2
Average
40% VE in
general
population
6
42%
48%
19%
52%
49%
47%
60%
56%
41%
37%
52%
21%
10%
2016-17
2015-16
2014-15
2013-14
2012-13
2011-12
2010-11
2009-10
2008-09
2007-08
2006-07
2005-06
2004-05
THE ELDERLY – AT RISK AND IN NEED
• ~90% of seasonal flu related death occurs in elderly
• Seasonal vaccine effectiveness as low as 9% for elderly1
• 86% of adults 65+ have chronic conditions2
• Influenza worsens outcomes of chronic illness
• Elderly flu cost in US estimated3 at $56B per year
(hospitalization, mortality, lost earnings)
1 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
2 https://www.ncoa.org/healthy-aging/flu-you/flu-facts/
3 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096
4 http://ije.oxfordjournals.org/content/35/2/352.short
NIH: “During the period from 1989 to 1997 the vaccination rate for
elderly persons ≥65 years of age in the US increased from 30 to 67%.
Despite this increase in coverage, mortality and hospitalization rates
continued to increase rather than decline as would be expected...”
International Journal of Epidemiology4 (Vol. 35, Issue 2, P352-353)
7
MEETING MILESTONES & CATALYSTS
2008
1st of two Phase
1/2 (IL)
May 2015
Nasdaq: BVXV
2010
1st of four
Phase 2 (IL, EU)
Technology developed
by Prof. Ruth Arnon
Mid 90’s
June 2007
TASE:BVXV
BiondVax
Operational
2005
EMA or EOP2M1
Phase 3 ready
2018
1 End of Phase 2 Meeting with the FDA or EMA prior to phase 3
Well known for the
development of
Solid Science, Advanced Clinical Stage, Strong IP
FDA accepts
IND
One • For All : The Universal Flu Vaccine
The Vaccine is Safe and Immunogenic
• 698 young adult to elderly have participated in clinical trials
• The vaccine was shown to be safe and immunogenic in all studies
2017
8
USA NIH Phase 2
USA CMO Phase 3 material
Mid-size manufacturing
plant construction
June 2017
€20M EIB
Successful
Phase 2b (EU)
THINKING OUTSIDE THE BOX
BiondVax’s M-001 Existing vaccines
Universal: Broad coverage Strain specific
Single formulation enabling
year-round vaccination
New vaccine every year
Quick, robust year-round
production (6-8 weeks)
Long (4-6 month)
production cycle
Induces cellular (CMI) and
enhances humoral (HAI priming
effect) immune response to flu
Limited vaccine
effectiveness
Target Common Regions
Nine common regions (epitopes) of flu
strains are connected to make one
recombinant protein called M-001
produced in E.coli
HemAgglutinin(HA)
NucleoProtein(NP)
Matrixprotein(M1)
The Influenza Virus
Universal Flu Vaccine
A common denominator for
Seasonal & Pandemic strains
BiondVax’s Key Advantages
One • For All : The Universal Flu Vaccine
9
M-001: ONE MULTI-SEASON & STRAIN FLU VACCINE
One • For All : The Universal Flu Vaccine
10
• The human immune system has two arms:
• Humoral: B-cells that produce antibodies.
• Cellular (CMI): T-cells that produce cytokines with anti-viral activities.
• Current flu vaccines mainly induce antibodies (HAI) against specific flu virus
strains (variable immunodominant regions of HA).
• However, viruses are intracellular parasites, thus mostly are out of reach of our
immune system’s antibodies. However, T-cells target viruses within host cells.
• M-001 was designed to induce T-cells that target common and conserved
regions of flu viruses and to produce anti-viral cytokines such as INF-gamma and
IL-2. Indirectly, M-001 has a T-cell priming effect that enhances B-cell (HAI)
responses to flu viruses.
• Thus, M-001’s dual mode of action potentially can offer multi-season and
multi-strain protection.
In the clinical trials we looked
for the intrinsic CMI M-001
immunogenicity compared to
baseline and it’s priming effect
SUCCESSFUL CLINICAL TRIALS
ResultsStatus
Total
Participants
Population (age)YearTrialPhase
M-001 was well
tolerated and a
cellular (CMI) and
humoral (priming
effect) immune
response was
observed
Completed63Younger Adults (18-49)2009BVX-0021/2
Completed60Older Adults (55-75)2010BVX-0031/2
Completed200Younger Adults (18-49)2011BVX-0042
Completed120Elderly (65+)2012BVX-0052
Completed36Older Adults (50-65)2015BVX-0062
Completed219EU Adults (18-60)2015-16BVX-007*2b
698
Ongoing collaboration with NIH180USA Adults (18-45)2016BVX-0082
In preparation7,700East EU Adults (50+)2018BVX-0103
One • For All : The Universal Flu Vaccine
M-001: Safe and Immunogenic in Young Adults to Elderly
11
* BVX-007 was conducted in collaboration with the EU’s UNISEC consortium
• No treatment-related severe adverse events
• Adverse events were mild to moderate
• All adverse events observed were transient
• Both cellular and humoral immunity were induced
0
0.05
0.1
0.15
0.2
0.25
0.3
A/Brisbane/10/07
H3N2
A/California/7/09
H1N1
A/Perth/16/09
H3N2
B/Brisbane/60/08 Flumist
%Positiveofallcells
Baseline Day 42 (after M-001 x2)*
*
0
0.05
0.1
0.15
0.2
0.25
0.3
A/Brisbane/10/07
H3N2
A/California/7/09
H1N1
A/Perth/16/09
H3N2
B/Brisbane/60/08 Flumist 2011
%positivecells(Mean+SE)
M-001 twice Day 0
M-001 twice Day 42* *
* *
**
M-001: DESIGNED FOR CELL MEDIATED IMMUNITY
* P<0.05
**P<0.07
12
*
*
*
1 Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the
elderly population. Vaccine 32 (2014) 5816–5823
Direct Evidence: CD8, CD4 T-cell Activated Cells Produce TH1 Cytokines (IFN-gamma, IL-2 & TNF-alpha)
BVX0051: CD8 & IFN-gamma in ElderlyBVX0051: CD4 & IFN-gamma in Elderly
“Multiple-Cytokine-
Producing Antiviral CD4
T Cells Are Functionally
Superior to Single-
Cytokine-Producing
Cells”
S Kannanganat et al, J VIROL, 2007,
81(16)8468–76
211
134
1347
663
347
0
-200
0
200
400
600
800
1000
1200
1400
high
any
low
any
high
2/3
low 2/3 high
combi
low
combi
%overplacebo
*
*
*
*
Single Double Triple
M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg
UNISEC (EU): 13 fold increase in responders expressing 2 cytokines (18-60 Y)
678
380
530
474
38
-23
-200
0
200
400
600
800
1000
high INF low INF highIL2 low il2 high
tnfa
low tnfa
%overplacebo
M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg
IFN-gamma IL-2 TNF-alpha
UNISEC (EU): statistically significant anti viral cytokines
* P<0.05 * P<0.05* P<0.05
H1N1 pandemic swine flu
M-001: DESIGNED FOR CELL MEDIATED IMMUNITY
13
0
10
20
30
40
50
60
70
TIV 2011/12 M-001 & TIV 2011/12
%Seroprotection(HAI)
*
“M-001 can provide broadened enhanced immunity
extending even to influenza strains destined to
circulate in future years.” – Vaccine 2
In 2011 we
administered M-001
to seniors 65+
(BVX005)
4 years later, 5 times
more seniors were
seroprotected from a
new epidemic strain
(A/Swiss) that didn’t
exist in 2011!
1. Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the
elderly population. Vaccine 32 (2014) 5816–5823
2. Lowell GH et al. Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune
responses against 2014/15 epidemic strain. Vaccine (2017)
Indirect Evidence: Extending T-Cell Priming Effect for Enhanced HAI Responses to Current Flu Vaccines
BVX0051: 2012, age 65+ YO
BVX003: 2009, age 55-75 YO
0
10
20
30
40
50
60
70
A/California/7/09 A/Perth/16/09 B/Brisbane/60/08
%Seroconversion
TIV Twice M-001 + TIV
*
0
10
20
30
40
50
60
70
80
A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08
%seroconversion
TIV Twice M-001 + TIV
* P<0.05
PIVOTAL CLINICAL EFFICACY PHASE 3 DESIGN
14
• Sample size: ~7,700 participants with flexible enrollment (TBD)
• Population: 50+ years old; stratification to <65> years old (TBD)
• Endpoint: Clinical efficacy by reduction of illness rate and severity
• Phase 3 ready: First cohort enrollment expected autumn 2018
Proposed Trial Design Season 1 Season 2 Season 3 (optional)
Day 1 Day 21 Day 180 Follow up Follow up
Experimental 1mg M-001 1mg M-001 Safety, PCR
and culture on
any ILI
(flu season)
PCR and culture
on any ILI
(flu season)
PCR and culture on
any ILI
(flu season)Control Placebo Placebo
Opportunity: Financing and Phase 2 Trial Results Leads to Clinical Efficacy Phase 3
One • For All : The Universal Flu Vaccine
Study title: A multicenter,
randomized, double-blind,
placebo-controlled pivotal
phase 3 trial to assess the
safety and clinical efficacy of
a M-001 influenza vaccine
administered intramuscularly
twice in old adults and
elderly (≥50 YO)
PRODUCTS NEED PRODUCTION
15
• From pilot GMP to mid-size GMP manufacturing facility (Israel)*
• Funding: EIB, BiondVax, and Israel’s Ministry of Economy & Industry
• Capacity: up to 20 million single-doses or 40 million doses (bulk) per year
• Year-round Production & Stockpile per market demand
Goal: Fully Integrated Pharma Operating Under International GMP Standards
* BiondVax is in collaboration with a US-based CMO for upscaling and optimization
BIONDVAX: FIRST-IN-CLASS, BEST-IN-CLASS
One • For All : The Universal Flu Vaccine
16
Player Technology Strength
Phase
Progress
ReportedPre-
clinical
I II
Synthetic protein
B- & T-cell peptides
(HA, M1, NP)
• Broad coverage
• Large # of human clinical trials
• Young to elderly
Q3-2017: Statistically significant
European Ph2b trial. UNISEC
consortium. Commencing trial in
USA under NIAID/NIH
4 T-cell peptides adjuvanted
formulation
• Small challenge trial
2015 Announced collaboration
with NIAID/NIH & Europe.
UNISEC consortium. 2016
Created Imutex with hVIVO
Adenovirus vector expressing
Influenza A conserved NP and M1
proteins
• T-cell boost when administered
with TIV
Preparing for Ph2 in 2000
participants. Oxford University
spinoff, raised £10m in 2016.
Broad seasonal and pandemic
candidate. T-cell booster
• Intranasal, replication deficient
adenovirus
Formerly ITS, Vaxin. Phase 2
expected start Q3-2017. Merged
PharmaAthene, listed on
NASDAQ
DNA constructs encoding HA
proteins
• Versatile technology of mix and
match
Q3-2012 Phase 1
Single replication virus, M2SR
Broadening immunogenicity to
flu sub type H3N2
• Immunogenic in mice
Q3-2016 Phase I, H3N2
Raised $27m, including $5.5m
Aug 2017
Stem-only immunogens based on
rational design
• Innovative approach,
heterosubtypic protection in mice,
ferrets, primates
Q3-2015
Results in animals
Academic Labs
N=698
N=373
N=150
N=60
N=49
N=96
SUMMARY FINANCIAL DATA
Financial Data Highlights
• Successful IPO on Nasdaq in May 2015, $10M gross proceeds
• €20M EIB non-dilutive funding agreement1 signed June 2017
• Secondary offering Sept 2017, $10M gross proceeds
• Lean structure with 15 employees
• 6.5M outstanding ADS (8.8M fully diluted)2
• IFRS; calendar year basis
Balance Sheet Highlights
• >$22M cash on hand, no debt ~$30M total investment to date
• Current burn is ~$250K/month
• Ongoing clinical studies sponsored by 3rd parties
• $4.8M royalty-based liabilities from OCS grants (Office of the Israeli
Chief Scientist grants, off balance sheet)
BVXV
BVXVW
American Depository Shares ticker:
17
1 European Investment Bank (EIB) €20M support for M-001 Phase 3 trials and commercial production also includes:
• Zero-percent fixed interest loan for five years after each of the 3 drawdowns
• Variable remuneration based on royalties of net sales
• Milestone based drawdowns. Ultimate milestone includes regulatory authorization to launch Phase 3 trial
2 1 ADS = 40 ordinary shares
BVXV
Ordinary Shares ticker:
Intent to voluntarily delist from
TASE announced 31 August 2017
FLU VACCINES – A LARGE AND GROWING MARKET
Global Flu Vaccine Sales - 2015
$1,435M6
$410M5
$290M8
$652M7
Flu Vaccine Market
Seasonal Flu
o Worldwide: $4B global market in 20151;
expected to grow to $5.3B2 by 2021
o US: $1.4B in 2012 growing to $2.6B by 20222
o ~140M doses in just the US2
o Forecasted CAGR of 5.7%2
Pandemic Flu
o Swine Flu (A/H1N1) 2009 + first half of 2010
sales: ~$6.4B worldwide by Novartis, GSK and
Sanofi (on top of seasonal flu vaccine sales)3
“…part of the national strategy for pandemic
influenza, the United States’ plan is to stockpile enough
pre-pandemic influenza vaccines to cover 20 million in
the critical workforce.”4
“The United States has spent approximately $1 billion
in these [H5N1 flu vaccine stockpile] efforts to date.”4
2014: GSK bought Novartis’
vaccine unit except the Flu
2014: CSL bought Novartis’
Flu vaccine unit
2015: Rebrands to Seqirus
Others
2014: Pfizer bought
Baxter’s Flu vaccine unit
18
(1) http://www.cnbc.com/2015/10/19/the-16-billion-business-of-flu.html (2) Datamonitor report: DMKC0107117, Publication Date: 18/11/2013 (3) http://www.reports-research.com/news/datamonitor-vaccine-market-overview-
2010.html [Accessed 20 Nov 2016] (4) http://www.who.int/immunization/sage/meetings/2013/november/SAGE_WG_H5vaccine_background_paper_16Oct2013_v4.pdf (5) GSK, http://us.gsk.com/en-us/about-us/what-we-
do/vaccines/ (6) Sanofi, http://en.sanofi.com/Images/40570_20160209_Results-2015_presentation.pdf, slide 11 [At 31 Dec 2015 exchange rate of 1.08573] (7) CSL/Seqirus, http://annualreport.csl.com.au/year-in-review/seqirus.htm
(8) FiercePharma, http://www.fiercepharma.com/pharma/astrazeneca-s-flumist-shunned-by-cdc-group-resulting-80-million-inventory-hit [5,6,7,8 Accessed 25 January 2017]
Sanofi
36%
Seqirus / CSL
(Novartis)
16%
GSK
10%
AZ 7%
Others
31%
MANAGEMENT
One • For All : The Universal Flu Vaccine
Ron Babecoff
DMV, MEI
Tamar Ben-
Yedidia
PhD
Uri Ben-Or
CPA, MBA
Shimon Hassin
PhD
Joshua
Phillipson
Hon. BSc
Kenny Green
Msc, Mres
Founder,
President & CEO
CSO CFO COO BD Manager Investor Relations
•Degree from University of
Liège (ULG)
•Master in
Entrepreneurship &
Innovation (ISEMI,
Swinburne)
•Omrix Biopharmaceuticals
Ltd (Marketing Manager)
•Dexcel Pharma (Regional
Export Manager)
• Co-inventor of the
universal flu vaccine
• Degree from Weizmann
Institute of Science
• Biotechnology General
Ltd.
• Degree from College of
Administration
• Glycominds Ltd. (VP
Finance)
• Menorah Capital Markets
(Comptroller)
• Degree from University of
Maryland Biotechnology
Institute
• Kadimastem (CEO)
• InSight
Biopharmaceuticals (Head
of Bioprocessing)
• Hon. BSc. from University
of Toronto
• Accenture (Business
Management Consultant)
• BioData Ltd. (Marketing
Manager)
• Masters in Management
Degree from Cambridge
University & Master of
Research from University
of London
• IR for leading public
Israeli companies
including Elbit Systems
and Tower
Semiconductor
19
One • For All : The Universal Flu Vaccine
BOARD OF DIRECTORS
Board
Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman,
Steering committee)
Prof. Avner Rotman, PhD
Chairman of the Board
Rosen Partners LLC (Founder), CompreMedx Chairman), Kuala Healthcare
(CEO & President), Fusion Telecommunications (Director)
Mr. Jack Rosen
Director
ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital
(Consultant)
Dr. George Lowell, MD
Director
Omrix Pharmaceuticals Ltd (Marketing Manager), Dexcel Pharma
Technologies Ltd. (Formerly Dexxon, Regional Export Manager))
Ron Babecoff, DMV, MEI
Founder, President and CEO
Credit Suisse First Boston (Investment Banking), Private equity and venture
capital funds (Founder)
Mr. Isaac Devash, MBA
Director
Linkury Technology International Group (CFO), Union Bank, Spectronix,
Biomedix incubator, ADO group, Arko holdings, Algomizer (Director)
Mrs. Michal Marom Brikman, CPA
Director
Mor Langermann (Co-CEO), Medical Compression Systems Ltd (CFO),
Excellence Gemel & Pension Funds (External Director)
Mr. Ori Mor
Director
BioSight Ltd (CEO, Director), SHL Telemedicine (Director), Cellect
Biotechnology (Director)
Dr. Ruth Ben Yakar, PhD
Director
20
One • For All : The Universal Flu Vaccine
21
Expiration
Date
ADS
Equivalent
Exercise
price
NIS ($)
%
ADS
Equivalent
Shares
Outstanding26 Sept 2017
ADS-Shares 1:40 ratio
74.02%6,535,490261,419,599Ordinary shares
Employees
Variable
$ 7.20
NIS 0.70
($ 0.18)
3.49%308,48812,339,503Options
Oct 29, 2017$ 15.60
NIS 1.50
($ 0.39)
1.78%157,5506,302,000Options (Series 5)
May 5, 2020$ 6.2519.97%1,762,89770,515,880ADS Warrants
May 11, 2020$ 6.250.74%65,4252,617,000
Warrants issued to
underwriters
100.00%8,829,850353,193,982
Fully Diluted Shares
Outstanding
CAP TABLE
IP: COMPREHENSIVE AND EXPANDING COVERAGE
Updated: July 2017One • For All : The Universal Flu Vaccine
22 22
ExpiryStatus
Priority &
Assignee
Subject Matter
International
Publication
Title
Nov 2019
(Aug 2020
for US)
Granted: USA, Israel, Australia, Korea, Mexico, New Zealand,
Canada, Hong Kong, Belgium, France, Germany, Italy,
Netherlands, Spain, Switzerland, UK
11/30/1998
Yeda R&D
licensed to
BiondVax
Vaccine comprising
different epitopes
of the virus
WO 00/032228
Peptide-Based Vaccine for
Influenza
Dec 2026
(Jan 2027
for US)
Granted: USA, Australia, Austria, Belgium, Canada, Denmark,
France, Germany, Greece, Ireland, Israel, Italy, Luxembourg,
Netherlands, Portugal, Sweden, Spain, Switzerland, UK
12/6/2005
Yeda R&D
licensed to
BiondVax
Wide–range
vaccines – broad
strain and
extended
protection
WO 2007/066334
Improved Influenza
Vaccine
Aug 2028
(Aug 2031
for US)
Granted: USA, Mexico, Russia, Australia, China, Hong Kong, Japan,
Austria, Belgium, Croatia, Czech Republic, Denmark, Finland,
France, Germany, Hungary, Ireland, Italy, Luxembourg,
Netherlands, Poland, Portugal, Romania, Spain, Sweden,
Switzerland, Turkey, UK, Korea, Israel
Filed: Brazil
Allowed: Canada
Under Examination: India
8/2/2007
BiondVax
Vaccines
comprising multiple
copies of several
epitopes – current
product
WO 2009/016639
Multimeric Multi-Epitope
Influenza Vaccines
Feb 2031
Granted: USA, Australia
Under Examination: Canada
BiondVax
Use of Multimeric
as a primer to
conventional
vaccines
WO 2012/114323
Multimeric Multi-Epitope
Polypeptides in improved
Seasonal and Pandemic
Influenza Vaccines
April 2035
Filed: Australia, Canada, Europe, India, China, Hong Kong, Japan,
Israel, USA
4/3/2014
BiondVax
Production &
formulation
WO 2015/151103
Vaccine Compositions of
Multimeric Multi-epitope
Influenza Polypeptides
and their Production
THANK YOU!
CONTACT INFORMATION:
JOSHUA PHILLIPSON
j.phillipson@biondvax.com
+972-8-930-2529
www.biondvax.com
A game changer
for the world
healthcare system

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The Universal Flu Vaccine: One for All Seasons and Strains

  • 2. This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction. All statements in this communication, other than those relating to historical facts, are "forward-looking statements" within the meaning of the United States Private Litigation Reform Act of 1995.You can identify forward-looking statements by terms including ‘‘anticipates,’’ ‘‘believes,’’ ‘‘could,’’ ‘‘estimates,’’ ‘‘expects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘plans,’’ ‘‘potential,’’ ‘‘predicts,’’ ‘‘projects,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would,’’ and similar expressions intended to identify forward-looking statements. These forward- looking statements relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business, operations and financial performance and condition. However, these forward-looking statements are not guarantees of future performance and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, among others: the risk that drug development involves a lengthy and expensive process with uncertain outcome; BiondVax's ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize BiondVax's products; the difficulty in evaluating business prospects; lack of sufficient funding to finance the clinical trials; termination of license agreement with Yeda which is the owner of certain patents, patent applications and other intellectual property, as a result of dispute that can arise with Yeda or the failure of BiondVax to comply with financial and other terms of the license; the difficulty of predicting actions of the U.S.A FDA; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; changes in the global pharmaceutical industry; changes in customers’ budgeting priorities; European Medicines Agency and other regulatory authority approvals; natural disasters; labor disputes; rising interest rates; general market, political or economic conditions in the countries in which we operate; pension and health insurance liabilities; volatility or crises In the financial market; arbitration, litigation and regulatory proceedings; and war or acts of terror; Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. Readers are urged to carefully review and consider the various disclosures made in the Company’s SEC reports, which are designed to advise interested parties of the risks and factors that may affect its business, financial condition, results of operations and prospects. These forward-looking statements speak only as of the date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. whether as a result of new information, future events or otherwise, except as required by law. SAFE HARBOR STATEMENT One • For All : The Universal Flu Vaccine 2
  • 3. BIONDVAX’S 2017 HIGHLIGHTS 1. http://www.biondvax.com/2017/06/biondvaxs-ceo-provides-first-half-2017-general-corporate-update/ 2. http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/ 3. http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/ 4. http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/ 5. http://www.biondvax.com/2017/09/biondvax-announces-closing-of-10-million-public-offering-of-american-depositary-shares-and-exercise-of-over-allotment-option/ 3 €20 million non-dilutive funding2 – June 19 The European Investment Bank (EIB) signed an agreement to support commercial scale production and Phase 3 BiondVax successfully meets Phase 2b clinical trial endpoints3 – July 20 M-001 showed statistically significant elevated T-cell immune responses, good safety profile and well-tolerated Israeli government support mid-size commercial facility4 – March 30 Ministry of Economy granted 20% of a NIS 20m budget towards construction $10 million secondary offering5 – September 18 Following the placement, BiondVax has 3 large strategic investors, each holding 5% to 20% “…We now have the resources to launch our Phase 3 program towards commercialization.” 1
  • 4. Flu infects up to 20% of the population each year … and kills
  • 5. The Flu Virus: Frequent and Unpredictable Mutations A SEASONAL PROBLEM… A PANDEMIC THREAT SEASONAL FLU • Per year: 23,000 deaths1 (21,000 elderly) & 200,000 hospitalizations2 in just the US • 8th leading cause of death3 (US), Worldwide death toll of 250,000-500,000 annually4 • $87B economic burden5 in the US of which $56B is in the elderly PANDEMIC FLU • When?… Where?... Which?… pandemic strain • Pandemic strain: a new to Humans • Past century: 4 major pandemics with over 100M deaths5 • The 1918 Spanish Flu cost to global GDP6 was 4.8% or over $3T in today’s dollars Bill Gates interviewed by Ezra Klein on VOX “I rate the chances of a widespread epidemic in my lifetime at well over 50%” https://youtu.be/9AEMKudv5p0 5 1 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5933a1.htm#tab2; 2 http://www.cdc.gov/flu/about/qa/disease.htm; 3 http://www.cdc.gov/nchs/fastats/deaths.htm; 4 http://www.who.int/mediacentre/factsheets/fs211/en/ 5 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096; 6 1918 Influenza: the Mother of All Pandemics, Volume 12, Number 1—January 2006, CDC; 7 World Bank 2014:Pandemic Risk
  • 6. CURRENT VACCINE FALLS SHORT: THE MISMATCH 1 Center for Disease Control: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm 2 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf Seasonal Flu Vaccine Effectiveness (VE) CDC data 1 , flu seasons 2004-2017 Why current solutions fall short… • Past strains selection  Mismatch phenomenon • Previous season’s vaccine will not necessarily protect against next season’s flu strains • 4-6 month production lag As low as 9% VE in elderly2 Average 40% VE in general population 6 42% 48% 19% 52% 49% 47% 60% 56% 41% 37% 52% 21% 10% 2016-17 2015-16 2014-15 2013-14 2012-13 2011-12 2010-11 2009-10 2008-09 2007-08 2006-07 2005-06 2004-05
  • 7. THE ELDERLY – AT RISK AND IN NEED • ~90% of seasonal flu related death occurs in elderly • Seasonal vaccine effectiveness as low as 9% for elderly1 • 86% of adults 65+ have chronic conditions2 • Influenza worsens outcomes of chronic illness • Elderly flu cost in US estimated3 at $56B per year (hospitalization, mortality, lost earnings) 1 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf 2 https://www.ncoa.org/healthy-aging/flu-you/flu-facts/ 3 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096 4 http://ije.oxfordjournals.org/content/35/2/352.short NIH: “During the period from 1989 to 1997 the vaccination rate for elderly persons ≥65 years of age in the US increased from 30 to 67%. Despite this increase in coverage, mortality and hospitalization rates continued to increase rather than decline as would be expected...” International Journal of Epidemiology4 (Vol. 35, Issue 2, P352-353) 7
  • 8. MEETING MILESTONES & CATALYSTS 2008 1st of two Phase 1/2 (IL) May 2015 Nasdaq: BVXV 2010 1st of four Phase 2 (IL, EU) Technology developed by Prof. Ruth Arnon Mid 90’s June 2007 TASE:BVXV BiondVax Operational 2005 EMA or EOP2M1 Phase 3 ready 2018 1 End of Phase 2 Meeting with the FDA or EMA prior to phase 3 Well known for the development of Solid Science, Advanced Clinical Stage, Strong IP FDA accepts IND One • For All : The Universal Flu Vaccine The Vaccine is Safe and Immunogenic • 698 young adult to elderly have participated in clinical trials • The vaccine was shown to be safe and immunogenic in all studies 2017 8 USA NIH Phase 2 USA CMO Phase 3 material Mid-size manufacturing plant construction June 2017 €20M EIB Successful Phase 2b (EU)
  • 9. THINKING OUTSIDE THE BOX BiondVax’s M-001 Existing vaccines Universal: Broad coverage Strain specific Single formulation enabling year-round vaccination New vaccine every year Quick, robust year-round production (6-8 weeks) Long (4-6 month) production cycle Induces cellular (CMI) and enhances humoral (HAI priming effect) immune response to flu Limited vaccine effectiveness Target Common Regions Nine common regions (epitopes) of flu strains are connected to make one recombinant protein called M-001 produced in E.coli HemAgglutinin(HA) NucleoProtein(NP) Matrixprotein(M1) The Influenza Virus Universal Flu Vaccine A common denominator for Seasonal & Pandemic strains BiondVax’s Key Advantages One • For All : The Universal Flu Vaccine 9
  • 10. M-001: ONE MULTI-SEASON & STRAIN FLU VACCINE One • For All : The Universal Flu Vaccine 10 • The human immune system has two arms: • Humoral: B-cells that produce antibodies. • Cellular (CMI): T-cells that produce cytokines with anti-viral activities. • Current flu vaccines mainly induce antibodies (HAI) against specific flu virus strains (variable immunodominant regions of HA). • However, viruses are intracellular parasites, thus mostly are out of reach of our immune system’s antibodies. However, T-cells target viruses within host cells. • M-001 was designed to induce T-cells that target common and conserved regions of flu viruses and to produce anti-viral cytokines such as INF-gamma and IL-2. Indirectly, M-001 has a T-cell priming effect that enhances B-cell (HAI) responses to flu viruses. • Thus, M-001’s dual mode of action potentially can offer multi-season and multi-strain protection.
  • 11. In the clinical trials we looked for the intrinsic CMI M-001 immunogenicity compared to baseline and it’s priming effect SUCCESSFUL CLINICAL TRIALS ResultsStatus Total Participants Population (age)YearTrialPhase M-001 was well tolerated and a cellular (CMI) and humoral (priming effect) immune response was observed Completed63Younger Adults (18-49)2009BVX-0021/2 Completed60Older Adults (55-75)2010BVX-0031/2 Completed200Younger Adults (18-49)2011BVX-0042 Completed120Elderly (65+)2012BVX-0052 Completed36Older Adults (50-65)2015BVX-0062 Completed219EU Adults (18-60)2015-16BVX-007*2b 698 Ongoing collaboration with NIH180USA Adults (18-45)2016BVX-0082 In preparation7,700East EU Adults (50+)2018BVX-0103 One • For All : The Universal Flu Vaccine M-001: Safe and Immunogenic in Young Adults to Elderly 11 * BVX-007 was conducted in collaboration with the EU’s UNISEC consortium • No treatment-related severe adverse events • Adverse events were mild to moderate • All adverse events observed were transient • Both cellular and humoral immunity were induced
  • 12. 0 0.05 0.1 0.15 0.2 0.25 0.3 A/Brisbane/10/07 H3N2 A/California/7/09 H1N1 A/Perth/16/09 H3N2 B/Brisbane/60/08 Flumist %Positiveofallcells Baseline Day 42 (after M-001 x2)* * 0 0.05 0.1 0.15 0.2 0.25 0.3 A/Brisbane/10/07 H3N2 A/California/7/09 H1N1 A/Perth/16/09 H3N2 B/Brisbane/60/08 Flumist 2011 %positivecells(Mean+SE) M-001 twice Day 0 M-001 twice Day 42* * * * ** M-001: DESIGNED FOR CELL MEDIATED IMMUNITY * P<0.05 **P<0.07 12 * * * 1 Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the elderly population. Vaccine 32 (2014) 5816–5823 Direct Evidence: CD8, CD4 T-cell Activated Cells Produce TH1 Cytokines (IFN-gamma, IL-2 & TNF-alpha) BVX0051: CD8 & IFN-gamma in ElderlyBVX0051: CD4 & IFN-gamma in Elderly “Multiple-Cytokine- Producing Antiviral CD4 T Cells Are Functionally Superior to Single- Cytokine-Producing Cells” S Kannanganat et al, J VIROL, 2007, 81(16)8468–76 211 134 1347 663 347 0 -200 0 200 400 600 800 1000 1200 1400 high any low any high 2/3 low 2/3 high combi low combi %overplacebo * * * * Single Double Triple M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg UNISEC (EU): 13 fold increase in responders expressing 2 cytokines (18-60 Y) 678 380 530 474 38 -23 -200 0 200 400 600 800 1000 high INF low INF highIL2 low il2 high tnfa low tnfa %overplacebo M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg IFN-gamma IL-2 TNF-alpha UNISEC (EU): statistically significant anti viral cytokines * P<0.05 * P<0.05* P<0.05
  • 13. H1N1 pandemic swine flu M-001: DESIGNED FOR CELL MEDIATED IMMUNITY 13 0 10 20 30 40 50 60 70 TIV 2011/12 M-001 & TIV 2011/12 %Seroprotection(HAI) * “M-001 can provide broadened enhanced immunity extending even to influenza strains destined to circulate in future years.” – Vaccine 2 In 2011 we administered M-001 to seniors 65+ (BVX005) 4 years later, 5 times more seniors were seroprotected from a new epidemic strain (A/Swiss) that didn’t exist in 2011! 1. Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the elderly population. Vaccine 32 (2014) 5816–5823 2. Lowell GH et al. Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain. Vaccine (2017) Indirect Evidence: Extending T-Cell Priming Effect for Enhanced HAI Responses to Current Flu Vaccines BVX0051: 2012, age 65+ YO BVX003: 2009, age 55-75 YO 0 10 20 30 40 50 60 70 A/California/7/09 A/Perth/16/09 B/Brisbane/60/08 %Seroconversion TIV Twice M-001 + TIV * 0 10 20 30 40 50 60 70 80 A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08 %seroconversion TIV Twice M-001 + TIV * P<0.05
  • 14. PIVOTAL CLINICAL EFFICACY PHASE 3 DESIGN 14 • Sample size: ~7,700 participants with flexible enrollment (TBD) • Population: 50+ years old; stratification to <65> years old (TBD) • Endpoint: Clinical efficacy by reduction of illness rate and severity • Phase 3 ready: First cohort enrollment expected autumn 2018 Proposed Trial Design Season 1 Season 2 Season 3 (optional) Day 1 Day 21 Day 180 Follow up Follow up Experimental 1mg M-001 1mg M-001 Safety, PCR and culture on any ILI (flu season) PCR and culture on any ILI (flu season) PCR and culture on any ILI (flu season)Control Placebo Placebo Opportunity: Financing and Phase 2 Trial Results Leads to Clinical Efficacy Phase 3 One • For All : The Universal Flu Vaccine Study title: A multicenter, randomized, double-blind, placebo-controlled pivotal phase 3 trial to assess the safety and clinical efficacy of a M-001 influenza vaccine administered intramuscularly twice in old adults and elderly (≥50 YO)
  • 15. PRODUCTS NEED PRODUCTION 15 • From pilot GMP to mid-size GMP manufacturing facility (Israel)* • Funding: EIB, BiondVax, and Israel’s Ministry of Economy & Industry • Capacity: up to 20 million single-doses or 40 million doses (bulk) per year • Year-round Production & Stockpile per market demand Goal: Fully Integrated Pharma Operating Under International GMP Standards * BiondVax is in collaboration with a US-based CMO for upscaling and optimization
  • 16. BIONDVAX: FIRST-IN-CLASS, BEST-IN-CLASS One • For All : The Universal Flu Vaccine 16 Player Technology Strength Phase Progress ReportedPre- clinical I II Synthetic protein B- & T-cell peptides (HA, M1, NP) • Broad coverage • Large # of human clinical trials • Young to elderly Q3-2017: Statistically significant European Ph2b trial. UNISEC consortium. Commencing trial in USA under NIAID/NIH 4 T-cell peptides adjuvanted formulation • Small challenge trial 2015 Announced collaboration with NIAID/NIH & Europe. UNISEC consortium. 2016 Created Imutex with hVIVO Adenovirus vector expressing Influenza A conserved NP and M1 proteins • T-cell boost when administered with TIV Preparing for Ph2 in 2000 participants. Oxford University spinoff, raised £10m in 2016. Broad seasonal and pandemic candidate. T-cell booster • Intranasal, replication deficient adenovirus Formerly ITS, Vaxin. Phase 2 expected start Q3-2017. Merged PharmaAthene, listed on NASDAQ DNA constructs encoding HA proteins • Versatile technology of mix and match Q3-2012 Phase 1 Single replication virus, M2SR Broadening immunogenicity to flu sub type H3N2 • Immunogenic in mice Q3-2016 Phase I, H3N2 Raised $27m, including $5.5m Aug 2017 Stem-only immunogens based on rational design • Innovative approach, heterosubtypic protection in mice, ferrets, primates Q3-2015 Results in animals Academic Labs N=698 N=373 N=150 N=60 N=49 N=96
  • 17. SUMMARY FINANCIAL DATA Financial Data Highlights • Successful IPO on Nasdaq in May 2015, $10M gross proceeds • €20M EIB non-dilutive funding agreement1 signed June 2017 • Secondary offering Sept 2017, $10M gross proceeds • Lean structure with 15 employees • 6.5M outstanding ADS (8.8M fully diluted)2 • IFRS; calendar year basis Balance Sheet Highlights • >$22M cash on hand, no debt ~$30M total investment to date • Current burn is ~$250K/month • Ongoing clinical studies sponsored by 3rd parties • $4.8M royalty-based liabilities from OCS grants (Office of the Israeli Chief Scientist grants, off balance sheet) BVXV BVXVW American Depository Shares ticker: 17 1 European Investment Bank (EIB) €20M support for M-001 Phase 3 trials and commercial production also includes: • Zero-percent fixed interest loan for five years after each of the 3 drawdowns • Variable remuneration based on royalties of net sales • Milestone based drawdowns. Ultimate milestone includes regulatory authorization to launch Phase 3 trial 2 1 ADS = 40 ordinary shares BVXV Ordinary Shares ticker: Intent to voluntarily delist from TASE announced 31 August 2017
  • 18. FLU VACCINES – A LARGE AND GROWING MARKET Global Flu Vaccine Sales - 2015 $1,435M6 $410M5 $290M8 $652M7 Flu Vaccine Market Seasonal Flu o Worldwide: $4B global market in 20151; expected to grow to $5.3B2 by 2021 o US: $1.4B in 2012 growing to $2.6B by 20222 o ~140M doses in just the US2 o Forecasted CAGR of 5.7%2 Pandemic Flu o Swine Flu (A/H1N1) 2009 + first half of 2010 sales: ~$6.4B worldwide by Novartis, GSK and Sanofi (on top of seasonal flu vaccine sales)3 “…part of the national strategy for pandemic influenza, the United States’ plan is to stockpile enough pre-pandemic influenza vaccines to cover 20 million in the critical workforce.”4 “The United States has spent approximately $1 billion in these [H5N1 flu vaccine stockpile] efforts to date.”4 2014: GSK bought Novartis’ vaccine unit except the Flu 2014: CSL bought Novartis’ Flu vaccine unit 2015: Rebrands to Seqirus Others 2014: Pfizer bought Baxter’s Flu vaccine unit 18 (1) http://www.cnbc.com/2015/10/19/the-16-billion-business-of-flu.html (2) Datamonitor report: DMKC0107117, Publication Date: 18/11/2013 (3) http://www.reports-research.com/news/datamonitor-vaccine-market-overview- 2010.html [Accessed 20 Nov 2016] (4) http://www.who.int/immunization/sage/meetings/2013/november/SAGE_WG_H5vaccine_background_paper_16Oct2013_v4.pdf (5) GSK, http://us.gsk.com/en-us/about-us/what-we- do/vaccines/ (6) Sanofi, http://en.sanofi.com/Images/40570_20160209_Results-2015_presentation.pdf, slide 11 [At 31 Dec 2015 exchange rate of 1.08573] (7) CSL/Seqirus, http://annualreport.csl.com.au/year-in-review/seqirus.htm (8) FiercePharma, http://www.fiercepharma.com/pharma/astrazeneca-s-flumist-shunned-by-cdc-group-resulting-80-million-inventory-hit [5,6,7,8 Accessed 25 January 2017] Sanofi 36% Seqirus / CSL (Novartis) 16% GSK 10% AZ 7% Others 31%
  • 19. MANAGEMENT One • For All : The Universal Flu Vaccine Ron Babecoff DMV, MEI Tamar Ben- Yedidia PhD Uri Ben-Or CPA, MBA Shimon Hassin PhD Joshua Phillipson Hon. BSc Kenny Green Msc, Mres Founder, President & CEO CSO CFO COO BD Manager Investor Relations •Degree from University of Liège (ULG) •Master in Entrepreneurship & Innovation (ISEMI, Swinburne) •Omrix Biopharmaceuticals Ltd (Marketing Manager) •Dexcel Pharma (Regional Export Manager) • Co-inventor of the universal flu vaccine • Degree from Weizmann Institute of Science • Biotechnology General Ltd. • Degree from College of Administration • Glycominds Ltd. (VP Finance) • Menorah Capital Markets (Comptroller) • Degree from University of Maryland Biotechnology Institute • Kadimastem (CEO) • InSight Biopharmaceuticals (Head of Bioprocessing) • Hon. BSc. from University of Toronto • Accenture (Business Management Consultant) • BioData Ltd. (Marketing Manager) • Masters in Management Degree from Cambridge University & Master of Research from University of London • IR for leading public Israeli companies including Elbit Systems and Tower Semiconductor 19
  • 20. One • For All : The Universal Flu Vaccine BOARD OF DIRECTORS Board Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman, Steering committee) Prof. Avner Rotman, PhD Chairman of the Board Rosen Partners LLC (Founder), CompreMedx Chairman), Kuala Healthcare (CEO & President), Fusion Telecommunications (Director) Mr. Jack Rosen Director ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital (Consultant) Dr. George Lowell, MD Director Omrix Pharmaceuticals Ltd (Marketing Manager), Dexcel Pharma Technologies Ltd. (Formerly Dexxon, Regional Export Manager)) Ron Babecoff, DMV, MEI Founder, President and CEO Credit Suisse First Boston (Investment Banking), Private equity and venture capital funds (Founder) Mr. Isaac Devash, MBA Director Linkury Technology International Group (CFO), Union Bank, Spectronix, Biomedix incubator, ADO group, Arko holdings, Algomizer (Director) Mrs. Michal Marom Brikman, CPA Director Mor Langermann (Co-CEO), Medical Compression Systems Ltd (CFO), Excellence Gemel & Pension Funds (External Director) Mr. Ori Mor Director BioSight Ltd (CEO, Director), SHL Telemedicine (Director), Cellect Biotechnology (Director) Dr. Ruth Ben Yakar, PhD Director 20
  • 21. One • For All : The Universal Flu Vaccine 21 Expiration Date ADS Equivalent Exercise price NIS ($) % ADS Equivalent Shares Outstanding26 Sept 2017 ADS-Shares 1:40 ratio 74.02%6,535,490261,419,599Ordinary shares Employees Variable $ 7.20 NIS 0.70 ($ 0.18) 3.49%308,48812,339,503Options Oct 29, 2017$ 15.60 NIS 1.50 ($ 0.39) 1.78%157,5506,302,000Options (Series 5) May 5, 2020$ 6.2519.97%1,762,89770,515,880ADS Warrants May 11, 2020$ 6.250.74%65,4252,617,000 Warrants issued to underwriters 100.00%8,829,850353,193,982 Fully Diluted Shares Outstanding CAP TABLE
  • 22. IP: COMPREHENSIVE AND EXPANDING COVERAGE Updated: July 2017One • For All : The Universal Flu Vaccine 22 22 ExpiryStatus Priority & Assignee Subject Matter International Publication Title Nov 2019 (Aug 2020 for US) Granted: USA, Israel, Australia, Korea, Mexico, New Zealand, Canada, Hong Kong, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, UK 11/30/1998 Yeda R&D licensed to BiondVax Vaccine comprising different epitopes of the virus WO 00/032228 Peptide-Based Vaccine for Influenza Dec 2026 (Jan 2027 for US) Granted: USA, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Luxembourg, Netherlands, Portugal, Sweden, Spain, Switzerland, UK 12/6/2005 Yeda R&D licensed to BiondVax Wide–range vaccines – broad strain and extended protection WO 2007/066334 Improved Influenza Vaccine Aug 2028 (Aug 2031 for US) Granted: USA, Mexico, Russia, Australia, China, Hong Kong, Japan, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, UK, Korea, Israel Filed: Brazil Allowed: Canada Under Examination: India 8/2/2007 BiondVax Vaccines comprising multiple copies of several epitopes – current product WO 2009/016639 Multimeric Multi-Epitope Influenza Vaccines Feb 2031 Granted: USA, Australia Under Examination: Canada BiondVax Use of Multimeric as a primer to conventional vaccines WO 2012/114323 Multimeric Multi-Epitope Polypeptides in improved Seasonal and Pandemic Influenza Vaccines April 2035 Filed: Australia, Canada, Europe, India, China, Hong Kong, Japan, Israel, USA 4/3/2014 BiondVax Production & formulation WO 2015/151103 Vaccine Compositions of Multimeric Multi-epitope Influenza Polypeptides and their Production
  • 23. THANK YOU! CONTACT INFORMATION: JOSHUA PHILLIPSON j.phillipson@biondvax.com +972-8-930-2529 www.biondvax.com A game changer for the world healthcare system